(84 days)
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
The MAGNETOM Espree System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that is currently available with MAGNETOM Avanto.
The provided text describes a 510(k) summary for the Siemens MAGNETOM Espree System, a Magnetic Resonance Diagnostic Device (MRDD). However, it does not contain the level of detail requested for acceptance criteria, specific study results, or statistical data typically associated with performance evaluations for AI/CADe devices.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Performance Levels" and "Action Levels" that the MAGNETOM Espree is expected to conform to, aligning with FDA guidance and NEMA/IEC standards. However, it does not provide specific quantitative acceptance criteria or the reported device performance measurements against these criteria.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Action Levels | Maximum Static Field | Not specified quantitatively |
| Rate of Change of Magnetic Field | Not specified quantitatively | |
| RF Power Deposition | Not specified quantitatively | |
| Acoustic Noise Levels | Not specified quantitatively | |
| Performance Levels | Signal to Noise | Not specified quantitatively |
| Image Uniformity | Not specified quantitatively | |
| Geometric Distortion | Not specified quantitatively | |
| Slice Profile, Thickness and Gap | Not specified quantitatively | |
| High Contrast Spatial Resolution | Not specified quantitatively |
The document states: "The MAGNETOM Espree will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto." This indicates that the device will conform rather than has demonstrated specific conformity results in this summary document.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the provided text. The submission focuses on substantial equivalence to a predicate device (Siemens MAGNETOM Avanto) based on hardware and operational similarities and adherence to general safety and performance standards, rather than a clinical study evaluating diagnostic performance with specific test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not present. As no specific diagnostic performance study on a test set is detailed, the concept of establishing ground truth by experts is not applicable in this document.
4. Adjudication Method for the Test Set:
This information is not present.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not present. The document does not describe any study comparing human reader performance with or without AI assistance. This device is a foundational imaging system, not an AI/CADe diagnostic aid that augments human readers.
6. Standalone (Algorithm Only) Performance:
This information is not present. The MAGNETOM Espree is an MR imaging system that produces images for human interpretation, not an algorithm providing diagnostic outputs independently.
7. Type of Ground Truth Used:
This information is not present. Given the nature of the device as an imaging system and the focus on substantial equivalence, the document doesn't discuss diagnostic ground truth as would be relevant for a CADe/AI device.
8. Sample Size for the Training Set:
This information is not present. There is no mention of a "training set" as this device is not an AI/machine learning product that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not present. This question is not applicable to the type of device and submission described.
In summary:
The provided 510(k) summary for the MAGNETOM Espree system demonstrates substantial equivalence to a predicate device (MAGNETOM Avanto) by highlighting similar hardware, intended use, and adherence to established safety and general performance standards (NEMA, IEC, FDA guidance for MRDDs). It does not provide details of specific clinical performance studies with acceptance criteria, test sets, or ground truth establishment as would be expected for AI/CADe devices or devices requiring specific diagnostic accuracy claims. The "study" referenced is the demonstration of conformity to recognized standards for the measurement of basic MRI performance and safety parameters, rather than a diagnostic accuracy trial.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.